Our services include:
- Adaptive Design
- Bayesian and Frequentist Analysis
- Phase I to Phase IV Trials
- Device Trials
- Sample Size Calculations
- Randomizations
- Statistical Analysis Plan
- Publication Support
- ISS/ISE Packages
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- STDM and ADaM Datasets
- CDISC Conversions
- CRF Design/Review
- AE Coding
- Double Data Entry
- Paper-based Studies
- EDC Vendor Management
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- Direct FDA interaction and presenting at panel meetings
- Device Submission Support; PMA,NDA and 510k
- Bayesian and Frequentist methods resulting in regulatory approvals
- Adaptive trial design proficiency and experience
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| 11/2/2011 | - | 13th Annual Southeast Bio Investor Forum, Nov 2nd-3rd, Durham, NC |
| 11/01/2011 | - | MedTech 11, Nov 1st-2nd, Chapel Hill, NC |
| 10/18/2011 | - | 2011 Musculoskeletal New Ventures Conference, Oct 18th-19th, Memphis, TN |
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